23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
FDA 510(k)
FDA Class 3
·Cardiovascular
Dreamway connector kit
FDA UDI
BLEEP, LLC·00850003157054·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450268971·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450229675·
HS Dia.Burr,coarse,Ø3.1x70,80k
FDA UDI
Bien-Air Surgery SA·17630055507065·
RESANO SIGMOID ANASTOMOSIS FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011519·RESANO SIGMOID ANASTOMOSIS FORCEPS
Zavation
FDA UDI
Zavation LLC·00842166175808·6.5mm Tap
Zavation
FDA UDI
Zavation LLC·00842166182103·Tap
Zavation
FDA UDI
Zavation LLC·00842166176454·6.5 mm Cannulated Tap
DYNATRON STS
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
CTB73, 12X100 KII SH BLD ZTHR 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 29, 2018
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 13, 2011
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE
FDA Adverse Event
Injury
·TORNIER INC·Product code JDC·May 7, 2024
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·August 16, 2018
CTS22, 12X100 KII SLEEVE ZTHR 12/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 29, 2018
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022